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Diss Factsheets

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 November 2016 - 18 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R,2S,3S,4R)-3-((5-fluoro-2-(5-fluoro-1-tosyl-1H-pyrrolo[2,3-b]pyridin-3-yl)pyrimidin-4-yl)amino)bicyclo[2.2.2]octane-2-carboxylic acid
EC Number:
821-185-1
Cas Number:
1777721-63-7
Molecular formula:
C27H25F2N5O4S
IUPAC Name:
(1R,2S,3S,4R)-3-((5-fluoro-2-(5-fluoro-1-tosyl-1H-pyrrolo[2,3-b]pyridin-3-yl)pyrimidin-4-yl)amino)bicyclo[2.2.2]octane-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
- Name of the test material (as cited in study reports): JNJ-63757109-AAA (T003690)
- Physical state: solid (powder)
- Appearance: white to slightly yellow power
Specific details on test material used for the study:
- Batch n°: I16BD1072
- Analytical purity: 100.0%
- Expiration date: 04 March 2018

Results and discussion

Relative self-ignition temperature (solids)
Key result
Remarks on result:
no self ignition observed under the test conditions

Any other information on results incl. tables

No significant endothermic or exothermic effect of the test item was observed between 20°C and 400°C. It demonstrated that the test item is not self-ignitable.

After the experiment, the test item had turned into a charred residue and was partially collected in a container that was placed below the cube. It indicated that the test item had decomposed and/or reacted during the experiment.

 

Applicant's summary and conclusion

Conclusions:
Based on the results of the EC A.16 test performed, the test item is considered ‘not self-ignitable’.
Because there were no indications of self-heating observed in this test, the test item was considered ‘not self-heating’ and the main study according to UN N.4 was not performed.